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GXPNews.com - FDA News and Announcements August 25 - August 29, 2014
The once a week newsletter reporting on what's new with the Food and Drug Administration (FDA)
   
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Whats New with CDER

August 29, 2014

August 28, 2014

August 27, 2014

August 26, 2014

August 25, 2014

August 22, 2014


Drug Approvals

August 28, 2014

Drug Name

Sponsor

Aleve Pm

Bayer Hlthcare

Avonex

Biogen

Decitabine

Sandoz Inc

Ella

Lab Hra Pharma

Frovatriptan Succinate

Mylan Pharms Inc

Ifex

Baxter Hlthcare

Ifex/Mesnex Kit

Baxter Hlthcare

Lamivudine and Zidovudine

Mylan Pharms Inc

Metformin Hydrochloride

Zydus Hlthcare

Oxycodone; Acetaminophen

Rhodes Pharms

Requip

Glaxosmithkline Llc

Requip Xl

Glaxosmithkline Llc

Rimso-50

Mylan Institutional

Stavzor

Banner Pharmacaps

Stribild

Gilead Sciences Inc

August 27, 2014

Drug Name

Sponsor

Clonazepam

Sun Pharm Inds Inc

Elelyso

Pfizer

Elelyso

Pfizer

Ella

Lab Hra Pharma

Megestrol Acetate

Twi Pharms Inc

Metoprolol Tartrate

Gland Pharma Ltd

Nephramine 5.4%

B Braun

Olopatadine Hydrochloride

Watson Labs Inc

Phoslyra

Fresenius Medcl

Vimovo

Horizon Pharma

Xopenex Hfa

Sunovion

August 26, 2014

Drug Name

Sponsor

Dostinex

Pharmacia and Upjohn

Entecavir

Teva Pharms Usa

Furosemide

Emcure Pharms Ltd

Memantine Hydrochloride

Macleods Pharms Ltd

Nevirapine

Mylan Labs Ltd

Primaxin

Merck

Promacta

Glaxosmithkline

Telmisartan

Zydus Pharms Usa Inc

Telmisartan and Amlodipine

Mylan Pharms Inc

Xalkori

Pf Prism Cv

August 25, 2014

Drug Name

Sponsor

Bacitracin

Xellia Pharms Aps

Buspirone Hydrochloride

Strides Arcolab Ltd

Diabeta

Sanofi Aventis Us

Faslodex

Astrazeneca

Invega Sustenna

Janssen Pharms

Kabiven and Perikabiven

Fresenius Kabi

Membraneblue

Dorc

Oxacillin Sodium

Agila Speclts

Tafinlar

Glaxosmithkline

Tricor

Abbvie

Visionblue

Dorc

August 22, 2014

Drug Name

Sponsor

Ampyra

Acorda

Dextrose 10% and Sodium Chloride 0.11% In Plastic Container

B Braun

Dextrose 10% and Sodium Chloride 0.2% In Plastic Container

B Braun

Dextrose 10% and Sodium Chloride 0.33% In Plastic Container

B Braun

Dextrose 10% and Sodium Chloride 0.45% In Plastic Container

B Braun

Dextrose 10% and Sodium Chloride 0.9% In Plastic Container

B Braun

Dextrose 10% In Plastic Container

B Braun

Dextrose 2.5% and Sodium Chloride 0.11% In Plastic Container

B Braun

Dextrose 2.5% and Sodium Chloride 0.2% In Plastic Container

B Braun

Dextrose 2.5% and Sodium Chloride 0.33% In Plastic Container

B Braun

Dextrose 2.5% and Sodium Chloride 0.45% In Plastic Container

B Braun

Dextrose 2.5% and Sodium Chloride 0.9% In Plastic Container

B Braun

Dextrose 2.5% In Half-Strength Lactated Ringer's In Plastic Container

B Braun

Dextrose 2.5% In Plastic Container

B Braun

Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container

B Braun

Dextrose 4% In Modified Lactated Ringer's In Plastic Container

B Braun

Dextrose 5% and Sodium Chloride 0.11% In Plastic Container

B Braun

Dextrose 5% and Sodium Chloride 0.2% In Plastic Container

B Braun

Dextrose 5% and Sodium Chloride 0.33% In Plastic Container

B Braun

Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

B Braun

Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

B Braun

Dextrose 5% In Lactated Ringer's In Plastic Container

B Braun

Dextrose 5% In Plastic Container

B Braun

Dextrose 5% In Sodium Chloride 0.45% In Plastic Container

Baxter Hlthcare

Dextrose 7.7% In Plastic Container

B Braun

Fexofenadine Hydrochloride

Aurolife Pharma Llc

Gilenya

Novartis

Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container

B Braun

Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Container

B Braun

Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container

B Braun

Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container

B Braun

Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container

B Braun

Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container

B Braun

Lidocaine Hydrochloride 0.2% and Dextrose 5% In Plastic Container

B Braun

Lidocaine Hydrochloride 0.4% and Dextrose 5% In Plastic Container

B Braun

Lidocaine Hydrochloride 0.8% and Dextrose 5% In Plastic Container

B Braun

Midazolam Hydrochloride

Bd Rx

Minocycline Hydrochloride

Mylan Pharms Inc

Minocycline Hydrochloride

Mylan Pharms Inc

Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container

B Braun

Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container

B Braun

Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container

B Braun

Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container

B Braun

Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container

B Braun

Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

B Braun

Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.037% In Dextrose 5% In Plastic Container

B Braun

Potassium Chloride 0.037% In Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container

B Braun

Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container

B Braun

Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.075% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container

B Braun

Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container

B Braun

Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container

B Braun

Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container

B Braun

Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

B Braun

Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.075% In Dextrose 5% In Plastic Container

B Braun

Potassium Chloride 0.075% In Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container

B Braun

Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container

B Braun

Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.11% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container

B Braun

Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container

B Braun

Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container

B Braun

Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container

B Braun

Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

B Braun

Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.11% In Dextrose 5% In Plastic Container

B Braun

Potassium Chloride 0.11% In Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container

B Braun

Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container

B Braun

Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.15% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container

B Braun

Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container

B Braun

Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container

B Braun

Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container

B Braun

Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

B Braun

Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.15% In Dextrose 5% In Plastic Container

B Braun

Potassium Chloride 0.15% In Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container

B Braun

Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container

B Braun

Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.22% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container

B Braun

Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container

B Braun

Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container

B Braun

Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container

B Braun

Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

B Braun

Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.22% In Dextrose 5% In Plastic Container

B Braun

Potassium Chloride 0.22% In Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container

B Braun

Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container

B Braun

Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.3% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container

B Braun

Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container

B Braun

Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container

B Braun

Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container

B Braun

Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container

B Braun

Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container

B Braun

Potassium Chloride 0.3% In Dextrose 5% In Plastic Container

B Braun

Potassium Chloride 0.3% In Sodium Chloride 0.9% In Plastic Container

B Braun

Prinivil

Merck

Rivastigmine Tartrate

Macleods Pharms Ltd

Theophylline 0.04% and Dextrose 5% In Plastic Container

B Braun

Theophylline 0.08% and Dextrose 5% In Plastic Container

B Braun

Theophylline 0.16% and Dextrose 5% In Plastic Container

B Braun

Theophylline 0.2% and Dextrose 5% In Plastic Container

B Braun

Theophylline 0.32% and Dextrose 5% In Plastic Container

B Braun

Theophylline 0.4% and Dextrose 5% In Plastic Container

B Braun

Tobramycin

Pulmoflow Inc

Triumeq

Viiv Hlthcare

Uceris

Santarus Inc

Zorvolex

Iroko Pharms Llc


CDER Workshops, Meetings and Conferences

Upcoming

  • PDA/FDA Joint Regulatory Conference and TRI Courses-Connecting Regulatory, Quality, Science & Compliance: Assuring Customer-Focused Outcomes Throughout the Product Lifecycle; September 8-10, 2014, Renaissance Hotel, Washington, D.C.  Meeting Informationdisclaimer icon
  • Public Workshop on the Clinical Development of Drugs to Prevent Infections Caused by Staphylococcus Aureus in the Healthcare Setting; September 5, 2014, The DoubleTree by Hilton Hotel, 8727 Colesville Road, Silver Spring, MD 20910. Meeting Information
  • Advancing the Use of Biomarkers and Pharmacogenomics; Notice of Public Meeting; Request for Comments. September 5, 2014. Meeting Information
  • Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments, September, 10-11, 2014, The DoubleTree by Hilton Hotel, The Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. 20910. Meeting information
  • FDA/PQRI Conference on Evolving Product Quality, September 16-17, 2014, Bethesda North Marriott Hotel and Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Meeting information
  • FDA’s GDUFA Public Hearing on Policy Development, September 17, 2014
  • FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Conference Fall 2014; September 18-19, 2014, Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, MD 20814. Meeting Information
  • FDA Public Workshop: Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer Workshop, October 21, 2014, Hyatt Regency Bethesda Hotel, One Bethesda Metro Center (7400 Wisconsin Avenue), Bethesda, MD 20814. Meeting information
  • The FDA, the Critical Path Institute (C-Path) and the Burroughs Wellcome Fund (BWF) are co-sponsoring the “First Annual Neonatal Scientific Workshop – Roadmap for Applying Regulatory Science to Neonates” – October 28 and 29, 2014 – FDA White Oak Campus – Great Room 1503 A. We would like to invite you all to participate in this workshop on October 28 and 29, 2014. Meeting Information
  •  Clinical Investigator Training Course, November 4-6, 2014, The Holiday Inn Washington, 10000 Baltimore Avenue, College Park, MD. Meeting information

This Weeks Warning Letters:

Letter Issue Date

Company Name

August 28, 2014

Blanc du Blanc, Inc.

August 28, 2014

I'm a Little Teacup

August 28, 2014

Petaware

August 18, 2014

HUMAN SCIENCE FOUNDATION

August 18, 2014

Simply Clean Air & Water Inc.

August 15, 2014

Zions Rx Formulations Services LLC dba Rx Formuations Serv.

Whats New with FDA


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

August 27, 2014

August 26, 2014

August 25, 2014

August 22, 2014


CDRH Workshops, Meetings and Conferences


Device Regulations

Electronic Systems Master Handbook 1

EU and US GMPs with ICH Q7, Q8(R2), Q9, Q10

Medical Device QSIT Manual with 11 and 820

Medical Device QSIT Manual with 11, 803, 806, 820 and 821

Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist

Medical Device Quality Systems Manual with 820 and QSR Audit Checklist

US, EU and Canadian Medical Device Combination

US, EU and Japanese GMPs

In Vitro Diagnostics 98/79/EC Medical Devices

21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master

3 Day On-Site FDA/EU GMP Training Fee - International

21 CFR 4 - cGMP for Combination Products

In Vitro Diagnostics Master Handbook

GMP International Master Reference Guide

 


Weekly Rule Changes
Monday - 21 CFR Parts 862, 864, 866, and 872

Friday, August 29, 2014

 

Notices

 

Determination That JADELLE (Levonorgestrel) Implant, 75 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

 

Pages 51575 - 51576 [FR DOC # 2014-20634]

PDF | Text

 
 

Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports; Availability

 

Pages 51576 - 51577 [FR DOC # 2014-20635]

PDF | Text

 

Thursday, August 28, 2014

 

Notices

 

Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis; Availability

 

Pages 51341 - 51342 [FR DOC # 2014-20483]

PDF | Text

 
 

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Electronic Exchange of Documents: File Format Recommendations; Availability

 

Pages 51342 - 51343 [FR DOC # 2014-20482]

PDF | Text

 
 

Risk Communications Advisory Committee; Notice of Meeting

 

Pages 51343 - 51344 [FR DOC # 2014-20481]

PDF | Text

 

Wednesday, August 27, 2014

 

Notices

 

Biosimilar User Fee Rates for Fiscal Year 2015; Correction

 

Pages 51178 - 51178 [FR DOC # 2014-20332]

PDF | Text

 
 

Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2015

 

Pages 51179 - 51180 [FR DOC # 2014-20360]

PDF | Text

 
 

Outsourcing Facility Fee Rates for Fiscal Year 2015; Correction

 

Pages 51184 - 51184 [FR DOC # 2014-20331]

PDF | Text

 
 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

 

Pages 51176 - 51178 [FR DOC # 2014-20276]

PDF | Text

 
 

Draft Guidance for Industry on Controlled Correspondence Related to Generic Drug Development; Availability

 

Pages 51180 - 51182 [FR DOC # 2014-20359]

PDF | Text

 
 

Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

 

Pages 51182 - 51183 [FR DOC # 2014-20291]

PDF | Text

 
 

Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Availability

 

Pages 51183 - 51184 [FR DOC # 2014-20394]

PDF | Text

 

Tuesday, August 26, 2014

 

Notices

 

Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

 

Pages 50916 - 50917 [FR DOC # 2014-20165]

PDF | Text

 

Monday, August 25, 2014

 

Rules and Regulations

 

Medical Devices; Technical Amendment

 

Pages 50551 - 50552 [FR DOC # 2014-20107]

PDF | Text

 
 

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Hemoglobin A1c Test System

 

Pages 50549 - 50551 [FR DOC # 2014-20022]

PDF | Text

 
 

Notices

 

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food

 

Pages 50656 - 50658 [FR DOC # 2014-20021]

PDF | Text

 
 

Advisory Committee Renewals

 

Pages 50658 - 50659 [FR DOC # 2014-20017]

PDF | Text

 
 

Determination That SULAR (Nisoldipine) Extended-Release Tablets, 10 Milligrams, 20 Milligrams, 25.5 Milligrams, 30 Milligrams, and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

 

Pages 50659 - 50660 [FR DOC # 2014-20043]

PDF | Text

 
 

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

 

Pages 50660 - 50661 [FR DOC # 2014-20016]

PDF | Text

 


 

GMP International Master Reference Guide

Dietary Supplement Master Handbook

21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master

21 CFR 210/211 - Drug GMPs

21 CFR 820 - Quality System Regulations

21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook

21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination

21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R1) - Good Clinical Practice Handbook

US, EU and Japanese GMPs

21 CFR 11, 210/211 - Electronic Records with Drug GMPs

21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH

21 CFR 11, 210/211 - Electronic Records with Drug GMPs-SPANISH

21 CFR 11, 210/211 with Keyword Index

21 CFR 11, 210/211, 606, 820 - Electronic Records with Drug, Blood and Device QSR Industry GMPs

21 CFR 11, 210/211, 700/701 - Cosmetic with "Is It Soap or a Drug"

21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs

21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs-SPANISH

21 CFR 11, 210/211, 820 with Audit Checklists - GMP Auditor’s Basic Handbook

21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook


21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs

21 CFR 11, 58, 210/211, 820, ICH E6(R1) - GMP 2 Combination Handbook

21 CFR 111 - Dietary Supplement handbook

21 CFR 200, 201 - General Drug & Drug Labeling Combination

21 CFR 210/211 - Drug GMPs

21 CFR 210/211 - Drug GMPs-ENGLISH/SPANISH

21 CFR 210/211 - Drug GMPs-SPANISH

21 CFR 210/211 with Drug Preambles

21 CFR 210/211 with Keyword Index

Canadian GMP Guidelines 2009, Version 2 - Effective March 4, 2011

EU and US GMPs with ICH Q7, Q8(R2), Q9, Q10

EU GMPs Chapter 1 - 9

EU GMPs with ICH Q7, Q8(R2), Q9 and Q10

GMP - PAT Handbook

US, EU and Japanese GMPs

Chinese GMPs -SFDA - State Food & Drug Administration P.R. CHINA

ICH Q7 with Q7 Auditors Check List

3 Day On-Site FDA/EU GMP Training Bootcamp - US

ICH Q7, Q8, Q9, Q10 and Q11

3 Day On-Site FDA/EU GMP Training Fee - International

21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master

GMP International Master Reference Guide

21 CFR 4 - cGMP for Combination Products

21 CFR 11, 210/211, 606, 820 - Electronic Records with Drug, Blood and Device QSR Industry GMPs

21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs

21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook

21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination

21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs

21 CFR 11, 58, 820 - Electronic Records with GLP and QSR

21 CFR 11, 820 - Electronic Records with Quality Systems Regulations

21 CFR 58, 820 - GLP and QSR

21 CFR 801 - Labeling - Medical Device

21 CFR 803 - Medical Device Reporting

21 CFR 806 - Medical Devices; Reports of Corrections and Removal

21 CFR 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices Rev. Oct. 1, 2012

21 CFR 809 - In-Vitro Diagnostic Products

21 CFR 810 - Medical Device Recall Authority

21 CFR 812 - Investigational Device Exemptions Rev. May 30, 2012

21 CFR 814 - Premarket Approval of Medical Device

21 CFR 820 - Quality System Regulations

21 CFR 820 - Quality System Regulations-SPANISH